Politicizing Science Biopharmaceutical Report I Issue12_December 2016 POLITICIZING SCIENCE BY STEVE USDIN, WASHINGTON EDITOR While the FDA reform provisions...
NY-ESO-1 therapy renewed enthusiasm underscored by new checkpoint inhibitors Biopharmaceutical Report III Issue11_September 2016 NY-ESO-1 targeting immunotherapies are seeing renewed clinical development interest...
Democratizing Antibodies Biopharmaceutical Report II Issue11_September 2016 “Will it be mammalian cells forever? Or is there an opportunity to get even better and...
FDA Review Policies for PD-1/PD-L1 Inhibitors Spark Expert Debate Biopharmaceutical Report I Issue11_September 2016 The potential for changes to FDA oncology drug application review and approval policies...
PCSK9 Inhibitor Competition: Amgen, Scanofi, and Regeneron Show Equally Decent CVOT Outlooks Biopharmaceutical Report II Issue10_July 2016 • Comparable CV effect expected across PCSK9 inhibitor class • Post-hoc MACE results in...
South Korea Trials Drive Further Opportunities for Global Pharma and CROs Biopharmaceutical Report I Issue10_July 2016 • Goals to improve regulation and site standards • Korean data used in Japanese...
Changing the Channel Overcoming Crisis : Reproducibility Initiatives Biopharmaceutical Report III Issue9_April 2016 --Strategy-- CHANGING THE CHANNEL By Mark...
Early CAR-T multiple myeloma data promising, though efficacy, safety remain unclear Biopharmaceutical Report II Issue9_April 2016 • Source of anti-CD19 CAR-Ts’ benefit obscure • Targeting multiple antigens may be...
Samsung RA biosimilar EU uptake tied to perceived cost despite physician concerns Biopharmaceutical Report I Issue9_April 2016 • Reference companies may lower drug prices too • Payers may mandate biosimilar use in...
Controlling Drug Prices Biopharmaceutical Report III Issue8_Novemver 2015 Goodwill Hunting Martin Shkreli and Hillary Clinton last week provided the flint and...
AbbVie’s Combination Drug for Hepatitis C has Elicited Mixed Expert Opinions Biopharmaceutical Report II Issue8_November 2015 • Success in vitro foreshadows pan-genotypic success • Six HCV genotypes have unique...
No Differentiation Expected Among PARP Inhibitors Biopharmaceutical Report I Issue8_November 2015 PARP inhibitors like Tesaro’s (NASDAQ:TSRO) niraparib, Clovis Oncology’s (NASDAQ:CLVS)...
RULES OF COMPETITION Biopharmaceutical Report III Issue7_August 2015 Competing in gene therapy is unlikely to follow the same rules as competing in other...
Seattle Genetics/Takeda’s Adcetris, likely to get label expansion Biopharmaceutical Report II Issue7_August 2015 Seattle Genetics (NASDAQ:SGEN) and Takeda Pharmaceutical’s (TYO:4502) Adcetris...
US Rheumatologists’ View on Biosimilars Biopharmaceutical Report I Issue7_August 2015 Rheumatologists in the US eagerly anticipate biosimilars for pricey anti-TNFs and other...
